Khazaie Sepideh, Mehra Reena, Bhambra Raman, Moul Douglas E, Foldvary-Schaefer Nancy, Vanek Robon, Bena James, Morrison Shannon, Walia Harneet K
Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Sleep Disorders Center, Department of Neurology, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Sleep Breath. 2025 Apr 4;29(2):149. doi: 10.1007/s11325-025-03319-x.
Positive airway pressure (PAP) is the mainstay of treatment for obstructive sleep apnea (OSA). However, suboptimal adherence significantly limits its effectiveness. This study examined the impact of a Sleep Apnea Management (SAM) clinic-an innovative, interactive group intervention providing interpersonal support, education, and resources-on PAP adherence and patient-reported outcomes (PROs) compared to usual care.
Participants with OSA who were newly prescribed PAP therapy and demonstrated suboptimal adherence (defined using CMS criteria during the first two weeks) were randomized to the SAM clinic (n = 26) or usual care (n = 30) from April 2019 to November 2022 (NCT-03835702). The primary outcome was the change in average daily PAP usage. Secondary outcomes included changes in the Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and PROMIS scales from baseline to 1 and 3 months. Baseline-adjusted mixed-effects linear and logistic models estimated differences between and within groups.
Fifty-six participants were enrolled with a mean age of 55 years, 57% female, 63% Caucasian, median AHI of 22.8 (IQR: 9.3,39.6), and median baseline PAP usage of 172 min. After 3 months, the mean (95% CI) SAM clinic daily PAP use was 193 (139, 247) minutes vs usual care at 148 (110, 185) minutes with a mean difference of 46(-8, 99) minutes per day (p = 0.093). Within each group, a mean daily difference of 11(-36,57) minutes (p = 0.65) in SAM clinic and -32(-75,12) (p = 0.15) in the usual care was observed. No significant differences were observed in PROs between SAM and usual care. Within each group, ESS change was -0.7(-2.5,1.2) (p = 0.48) in SAM clinic and -2.5(-4.2, -0.83) (p = .004) in usual care. Significant decrease was noted in PHQ-9 within both SAM clinic at-2.2(-3.9, -0.4) (p = 0.019) and in usual care at -2.3(-4.0, -0.7) (p = 0.006). Improvement in PROMIS sleep-related impairment was noted within both groups: SAM clinic at -3.0(-6.2,0.1) (p = 0.059) and usual care group at -3.5(-6.4, -0.60) (p = 0.019). Similar changes in PAP adherence and PROS were seen at the 1-month follow-up.
The SAM clinic demonstrated trends toward improved PAP adherence and PROs compared to usual care, though differences were not statistically significant, likely reflecting the study's small sample size and other methodological constraints, larger, adequately powered studies are needed to confirm these findings and further explore the impact of SAM clinics on PAP adherence and patient outcomes.
气道正压通气（PAP）是阻塞性睡眠呼吸暂停（OSA）治疗的主要方法。然而，依从性欠佳显著限制了其疗效。本研究比较了睡眠呼吸暂停管理（SAM）诊所（一种提供人际支持、教育和资源的创新型互动团体干预措施）与常规护理对PAP依从性及患者报告结局（PROs）的影响。
2019年4月至2022年11月期间，将新接受PAP治疗且依从性欠佳（根据前两周的CMS标准定义）的OSA参与者随机分为SAM诊所组（n = 26）或常规护理组（n = 30）（NCT-03835702）。主要结局是平均每日PAP使用时间的变化。次要结局包括从基线到1个月和3个月时，Epworth嗜睡量表（ESS）、患者健康问卷-9（PHQ-9）和PROMIS量表的变化。采用基线调整的混合效应线性和逻辑模型估计组间和组内差异。
共纳入56名参与者，平均年龄55岁，57%为女性，63%为白种人，平均呼吸暂停低通气指数（AHI）为22.8（四分位间距：9.3,39.6），基线PAP平均使用时间为172分钟。3个月后，SAM诊所组平均每日PAP使用时间为193（139, 247）分钟，常规护理组为148（110, 185）分钟，平均每日差异为46（-8, 99）分钟（p = 0.093）。在每组中，SAM诊所组平均每日差异为11（-36,57）分钟（p = 0.65），常规护理组为-32（-75,12）分钟（p = 0.15）。SAM诊所组与常规护理组在PROs方面未观察到显著差异。在每组中，SAM诊所组ESS变化为-0.7（-2.5,1.2）（p = 0.48），常规护理组为-2.5（-4.2, -0.83）（p = 0.004）。SAM诊所组和常规护理组的PHQ-9均显著下降，分别为-2.2（-3.9, -0.4）（p = 0.019）和-2.3（-4.0, -0.7）（p = 0.006）。两组的PROMIS睡眠相关损伤均有改善：SAM诊所组为-3.0（-6.2,0.1）（p = 0.059），常规护理组为-3.5（-6.4, -0.60）（p = 0.019）。在1个月随访时，PAP依从性和PROs的变化相似。
与常规护理相比，SAM诊所显示出PAP依从性和PROs改善的趋势，尽管差异无统计学意义，这可能反映了研究样本量小和其他方法学限制。需要更大规模、有足够统计学效力的研究来证实这些发现，并进一步探讨SAM诊所对PAP依从性和患者结局的影响。
